Clipboard, Search History, and several other advanced features are temporarily unavailable. Coprimary efficacy endpoints were radiographic progression-free survival (rPFS) in the intent-to-treat population and in patients with PTEN-loss tumors.
You have reached the maximum number of saved studies (100).Please remove one or more studies before adding more.The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ipatasertib plus abiraterone and prednisone/prednisolone compared with placebo plus abiraterone and prednisone/prednisolone in participants with metastatic castrate-resistant prostate cancer (mCRPC).Ipatasertib and abiraterone, administered orally, in 28-day cyclesOral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicityOral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water, plus prednisone/prednisolone, 5 mg twice daily (BID) until disease progression or intolerable toxicityPlacebo plus abiraterone, administered orally, in 28-day cyclesOral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water, plus prednisone/prednisolone, 5 mg twice daily (BID) until disease progression or intolerable toxicityOral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicityRadiographic progression-free survival is defined as time from date of randomization to the first occurrence of documented disease progression, as assessed by the investigator with use of the Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first. Ipatasertib is being studied in tumours that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Epub 2014 Mar 6.Clin Cancer Res. Partial response (PR) is defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.PSA response rate is defined as the percentage of participants achieving a PSA decline ≥50% from baseline.
Clin Cancer Res. HighWire 2020 Aug 14;3(1):440. doi: 10.1038/s42003-020-01175-x.Int J Mol Sci. Disease progression for bone lesions is defined as two or more lesions compared to baseline. 2019 Feb 1;25(3):901-903. doi: 10.1158/1078-0432.CCR-18-2491. Participants without a post-baseline PSA assessment will be considered non-responders.Investigator-assessed rPFS (time from date of randomization to the first occurrence of documented disease progression) per PCWG3 criteria will be analyzed in participants with PTEN-loss tumors by NGS.
Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT (protein kinase B), which blocks the PI3K/AKT signalling pathway – a key driver of cancer cell growth and proliferation in prostate cancer. 2020 Jun 12;12(6):1550. doi: 10.3390/cancers12061550.Biochem Soc Trans. doi: 10.1158/1078-0432.CCR-18-0981. Pain severity progression is defined as a ≥ 2-point absolute increase from baseline.Time to initiation of cytotoxic chemotherapy is defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy (use of antineoplastic agents: docetaxel, cabazitaxel, mitoxantrone, estramustine, cisplatin, carboplatin, cyclophosphamide, doxorubicin, mitomycin, irinotecan, 5-fluorouracil, gemcitabine, or etoposide) for prostate cancer.Overall Survival (OS) will be measured from randomization to the time of death due to any cause.Time to function deterioration is defined as the time interval from the date of randomization to the date of a decrease of 10-point or more on either the 0-100 physical function (PF) or the role functioning (RF) scores from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).Time to PSA progression is defined as the time from the date of randomization to the first occurrence of PSA progression, per the PCWG3 criteria.